ADVIHAIR SpA
⚠️ High Risk
FEI: 3013014062 • Zola Predosa, Bologna • ITALY
FEI Number
3013014062
Location
Zola Predosa, Bologna
Country
ITALYAddress
Via Benini 11, , Zola Predosa, Bologna, Italy
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/4/2025 | 53EA02HAIR SPRAYS (AEROSOL FIXATIVES) (HAIR PREPARATIONS, NON-COLORING) | 310POISONOUS | Division of West Coast Imports (DWCI) |
| 10/22/2024 | 79OAPLASER, COMB, HAIR | 47NON STD | Division of Southeast Imports (DSEI) |
| 3/6/2020 | 79OAPLASER, COMB, HAIR | Division of Southeast Imports (DSEI) | |
| 9/11/2019 | 79OAPLASER, COMB, HAIR | Division of Southeast Imports (DSEI) | |
| 12/15/2016 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 8/16/2016 | 53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | Cincinnati District Office (CIN-DO) | |
| 7/27/2016 | 79OAPLASER, COMB, HAIR | Cincinnati District Office (CIN-DO) | |
| 8/26/2015 | 53EY06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Florida District Office (FLA-DO) | |
| 4/20/2015 | 89ITGBANDAGE, CAST | Cincinnati District Office (CIN-DO) | |
| 1/21/2015 | 79OAPLASER, COMB, HAIR | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is ADVIHAIR SpA's FDA import refusal history?
ADVIHAIR SpA (FEI: 3013014062) has 10 FDA import refusal record(s) in our database, spanning from 1/21/2015 to 3/4/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. ADVIHAIR SpA's FEI number is 3013014062.
What types of violations has ADVIHAIR SpA received?
ADVIHAIR SpA has been cited for 8 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about ADVIHAIR SpA come from?
All FDA import refusal data for ADVIHAIR SpA is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.